xmlns:atom="http://www.w3.org/2005/Atom"

Statutory Instruments

2007 No. 2400

consumer protection

The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2007

Made

14th August 2007

Laid before Parliament

15th August 2007

Coming into force

7th September 2007

The Secretary of State makes the following Regulations in exercise of the powers conferred upon him by section 11 of the Consumer Protection Act 1987(1).

In accordance with section 11(5) of that Act he has consulted such organisations as appear to him to be representative of interests substantially affected by the following Regulations, such other persons as he considered appropriate and the Health and Safety Commission.

Citation, commencement, interpretation and revocation

1.—(1) These Regulations may be cited as the Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2007 and shall come into force on 7th September 2007.

(2) In these Regulations the “Principal Regulations” means the Cosmetic Products (Safety) Regulations 2004(2).

(3) The Regulations listed in Schedule 1 are revoked to the extent there specified.

Amendment of the Principal Regulations

2.—(1) The Principal Regulations are amended as follows.

(2) The following is substituted for paragraph 2(c) of regulation 5—

(c)any substance listed in column 2 of Schedule 4, unless the requirements in columns 3, 4, 5 and (in the case of Part II) 7 of that Schedule in relation to that substance are satisfied, except that, in relation to the substances listed in entry numbers 98 to 101, the prohibition shall not apply to the placing on the market of a cosmetic product before 23rd March 2008 or the sale or disposal to the final consumer of any such product before 24th June 2008;.

(3) The following is substituted for paragraph 15 of regulation 5—

(15) No cosmetic product containing any substance listed in Annex II to the Directive—

(a)under entry numbers 452 to 614 and 617 to 1132 (inserted into the Directive by Directive 2004/93/EC, entries 615 and 616 were omitted by Directive 2005/80/EC, entry 663 was amended by Directive 2007/1/EC and entry 687 was amended by Directive 2005/80/EC) shall be placed on the market or supplied;

(b)under entry numbers 1133 to 1136 (inserted into the Directive by Directive 2005/42/EC) shall be placed on the market or supplied;

(c)under entry numbers 1137 to 1181 and 1183 to 1211 (inserted into the Directive by Directive 2005/80/EC, entry 1182 was omitted by Directive 2007/1/EC) shall be placed on the market or supplied;

(d)under entry numbers 1212 to 1233 (inserted into the Directive by Directive 2006/65/EC) shall be placed on the market or supplied;

(e)under entry numbers 1234 to 1243 (inserted into the Directive by Directive 2007/1/EC) shall be sold or disposed of to the final consumer after 20th February 2008,

provided that no account shall be taken of any substance which is present only as a trace which could not reasonably have been removed during or after manufacture..

(4) At the end of Schedule 2 (List of Directives amending Directive 76/768/EEC) there is inserted—

48.  Commission Directive 2007/1/EC (O.J. No. L25, 01/02/2007, p.9).

49.  Commission Directive 2007/17/EC (O.J. No. L82, 23/03/2007, p.27)..

(5) At the end of Part 1 of Schedule 4 there are inserted the entries and end notes in Part 1 of Schedule 2 to these Regulations.

(6) Part 1 of Schedule 6 (List of preservatives which cosmetic products must not contain except subject to restrictions) is amended as follows—

(a)in column 5, “A” is deleted in entry numbers 1, 2, 4, 7, 12, 14, 18, 19, 21, 22, 24, 25, 26, 27, 28, 29, 30, 32, 33, 35, 37, 42 and 47;

(b)in column 5, “A” is inserted in entry numbers 5 and 43;

(c)for entry number 1 there are substituted the entries in Part 2 of Schedule 2 to these Regulations;

(d)for entry number 8 there is substituted the entry in Part 3 of Schedule 2 to these Regulations; and

(e)entry number 36 is deleted and there is inserted in its place in column 1 “ENTRY DELETED”.

(7) The changes made by regulation 2(6) to Schedule 6 shall not apply in relation to the placing on the market of any cosmetic product before 23rd March 2008 or the sale or disposal of any such product to a final consumer before 24th June 2008.

Malcolm Wicks

Minister of State for Energy

Department for Business, Enterprise & Regulatory Reform

14th August 2007

Regulation 1(3)

SCHEDULE 1Regulations revoked in whole or in Part

Regulation revokedReferenceExtent of revocation
The Cosmetic Products (Safety) (Amendment) (No.3) Regulations 2006S.I. 2006/2907All
The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2006S.I. 2006/2231Regulation 2(2)
The Cosmetic Products (Safety) (Amendment) Regulations 2006S.I. 2006/1198Regulation 2(2) and (3)
The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2005S.I. 2005/3346Regulation 2(2)

Regulation 2(5) and (6)

SCHEDULE 2

PART 1Entries inserted at the end of Part 1 of Schedule 4 to the Principal Regulations

(1) Reference Number(2) Name of substance(3) Purpose of substance or type of product(4) Maximum concentration of substance in product(5) Other requirements(6) Required information
(1)

As a preservative, see Schedule 6, Part 1, entry 3.

(2)

Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.

(3)

As a preservative, see Schedule 6, Part 1, entry 9.

(4)

As a preservative, see Schedule 6, Part 1, entry 23.

(5)

As a preservative, see Schedule 6, Part 1, entry 8.

98

Salicylic acid(1)

(CAS No 69-72-7)

a)

Rinse-off hair products

b)

Other products

a)

3.0 %

b)

2.0 %

Not to be used in preparations for children under three years of age, except for shampoos.

For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.

Not to be used for children under three years of age(2)
99Inorganic sulfites and bisulfites(3)
a)

Oxidative hair dye products

b)

Hair straightening products

c)

Self tanning products for the face

d)

Other self tanning products

a)

0.67% (expressed as free SO2)

b)

6.7% (expressed as free SO2)

c)

0.45% (expressed as free SO2 )

d)

0.40% (expressed as free SO2)

For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.
100

Triclocarban(4)

(CAS No 101-20-2)

Rinse-off products1.5%

Purity criteria:

3,3’,4,4’-Tetrachloroaz-obenzene ≤1mg/kg

3,3’,4,4’-Tetrachloroaz-oxybenzene ≤1mg/kg

For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.

101

Zinc

pyrithione(5)

(CAS No 13463-41-7)

Leave-on hair products0.1%For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.

PART 2Entries substituted for entry number 1 in Part 1 of Schedule 6 to the Principal Regulations

(1)

Reference Number

(2)

Name of Substance

(3)

Purpose of substance or type of product

(4)

Maximum concentration of substance in product

(5)

Other Require-ments

(6)

Required Information

1

Benzoic acid

(CAS No 65-85-0) and its sodium salt

(CAS No 532-32-1)

Rinse-off products, except oral care products: 2.5% (expressed as acid)

Oral care products: 1.7% (expressed as acid)

Leave-on products: 0.5% (expressed as acid)

1aSalts of benzoic acid other than that listed under reference number 1 and esters of benzoic acid0.5% (expressed as acid)

PART 3Entry substituted for entry number 8 in Part 1 of Schedule 6 to the Principal Regulations

(1)

Reference

Number

(2)

Name of

Substance

(3)

Purpose of

Substance or

type of product

(4)

Maximum concentration

of substance in product

(5)

Other requirements

(6)

Required information

8

Zinc pyrithione

(CAS No 13463-41-7)

Hair products: 1.0 %

Other products: 0.5%

Rinse-off products only.

No use in products for oral hygiene.

A

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Cosmetic Products (Safety) Regulations 2004 (S.I. 2004/2152) (“the Principal Regulations”). They give effect for the first time to Commission Directives 2007/1/EC (O.J. No L25, 01/02/2007, p.9) and 2007/17/EC (O.J. No. L82, 23/03/2007, p.27) which amend Council Directive 76/768/EEC (O.J. L262, 27.09.1976, p.169) on the approximation of the laws of the Member States relating to cosmetic products (“the Principal Directive”). The Principal Directive has been implemented by the Principal Regulations.

These Regulations also revoke provisions in the Regulations listed in Schedule 1 which previously gave effect to parts of the following Commission Directives which amended the Principal Directive: 2004/93/EC (O.J. L300 25/09/2004 p.13), 2005/42/EC (O.J. L158 21.6.2005 p.17), 2005/80/EC (O.J. L303 22/11/2005 p.32) and 2006/65/EC (O.J L198 20/07/2006 p.11).

Directive 2007/1/EC adds ten substances to those prohibited in hair dyes. Directive 2007/17/EC adds four substances to those which cosmetic products may not use except subject to restrictions and conditions and amends the list of preservatives which may be used in cosmetic products.

Regulation 2(2) amends regulation 5(2)(c) to allow cosmetic products containing the four additional substances to be placed on the market before 23rd march 2008 and disposed of to the final consumer until 23rd June 2008. These substances are added to Part 1 of Schedule 4 to the Principal Regulations by regulation 2(4) and Part 1 of Schedule 2.

Regulation 2(3) replaces paragraph 15 of regulation 5 with a consolidated list of cross references to Annex II to the Principal Directive as amended, incorporating the amendments made by Directive 2007/1/EC. Regulation 3 makes consequential revocations.

Regulation 2(5) and Parts 2 and 3 of Schedule 2 amend Part 1 of Schedule 6 to the Principal Regulations to give effect to the changes made by Directive 2007/17/EC.

A regulatory impact assessment of the effect that these Regulations will have on costs to businesses together with a transposition note is available from the Consumer and Competition Policy Directorate of the Department for Business, Enterprise & Regulatory Reform, 1 Victoria Street, London SW1H 0ET. The regulatory impact assessment is also available from the BERR website (www.berr.gov.uk) and is annexed to the Explanatory Memorandum which is available with the instrument on the OPSI website (www.opsi.gov.uk).

(1)

1987 c.43. Section 11(1) has been amended by S.I. 2005/1803.